Design and rationale of a randomized trial comparing the Blalock-Taussig and right ventricle-pulmonary artery shunts in the Norwood procedure.
OBJECTIVE
The initial palliative procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood procedure, remains among the highest risk procedures in congenital heart surgery. The classic Norwood procedure provides pulmonary blood flow with a modified Blalock-Taussig shunt. Improved outcomes have been reported in a few small, nonrandomized studies of a modification of the Norwood procedure that uses a right ventricle-pulmonary artery shunt to provide pulmonary blood flow. Other nonrandomized studies have shown no differences between the two techniques.


METHODS
The Pediatric Heart Network designed a randomized clinical trial to compare outcomes for subjects undergoing a Norwood procedure with either the right ventricle-pulmonary artery or modified Blalock-Taussig shunt. Infants with a diagnosis of single, morphologically right ventricle anomaly who are undergoing a Norwood procedure are eligible for inclusion in this study. The primary outcome is death or cardiac transplant 12 months after random assignment. Secondary outcomes include postoperative morbidity after Norwood and stage II palliation procedures, right ventricular function and pulmonary arterial growth at stage II palliation, and neurodevelopmental outcomes at 14 months old. Incidence of adverse events will also be compared between treatment groups.


CONCLUSIONS
This study will make an important contribution to the care of patients with hypoplastic left heart syndrome and related forms of single, morphologically right ventricle. It also establishes a model with which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.
Ohye
Richard G
RG
University of Michigan Medical School, Ann Arbor, Michigan, USA. ohye@umich.edu
Gaynor
J William
JW
Ghanayem
Nancy S
NS
Goldberg
Caren S
CS
Laussen
Peter C
PC
Frommelt
Peter C
PC
Newburger
Jane W
JW
Pearson
Gail D
GD
Tabbutt
Sarah
S
Wernovsky
Gil
G
Wruck
Lisa M
LM
Atz
Andrew M
AM
Colan
Steve D
SD
Jaggers
James
J
McCrindle
Brian W
BW
Prakash
Ashwin
A
Puchalski
Michael D
MD
Sleeper
Lynn A
LA
Stylianou
Mario P
MP
Mahony
Lynn
L
D006348:Cardiac Surgical Procedures / Q000379:methods* / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D018610:Heart Bypass, Right / Q000379:methods / Q000401:mortality; D006352:Heart Ventricles / Q000002:abnormalities / Q000601:surgery*; D006801:Humans; D018636:Hypoplastic Left Heart Syndrome / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D007231:Infant, Newborn; D008297:Male; D011183:Postoperative Complications / Q000401:mortality; D011446:Prospective Studies; D011651:Pulmonary Artery / Q000601:surgery*; D011652:Pulmonary Circulation / Q000502:physiology; D012107:Research Design; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome